Popular Diabetes Drug Avandia under Fire

The diabetes drug Avandia, manufactured by pharmaceutical giant GlaxoSmithKline, has been making headlines lately as FDA hearings evaluate the drug’s safety. Avandia has been under fire since June 2007, after a study published in the New England Journal of Medicine stated the drug significantly increases the risk of heart attack and heart failure.

But on Wednesday, July 14, an FDA advisory panel voted against a ban on the drug. The vote was split. Twelve members of the 33-person panel advised the FDA to take the drug off the market, while 20 others voted not to ban the drug. However, the latter group advocated for stronger warnings on the label, along with increased doctor and patient education about the drug’s risks.

Controversy over Clinical Trial

Avandia first became available in 1999 as an oral medication for the treatment of Type 2 diabetes. It belongs to a class of diabetes drugs known as thiazolidinediones.The FDA initially granted approval for the drug based on its ability to lower blood glucose and hemoglobin levels.

But in 2007, the results of a study published in the New England Journal of Medicine reported that the drug increased the risk of heart attack by 43 percent. According to the research, initial studies by GlaxoSmithKlinedid not adequately investigate the effects of the drug on cardiovascular outcomes. This effect is particularly important to evaluate, because more than 65% of diabetes patients die from heart disease.

Furthermore, GlaxoSmithKline has been accused of hiding unfavorable data on Avandia and for irregularities in handling and interpreting clinical trial data.

FDA Panel Conclusions

The majority of panel members agree that data suggest that Avandia increases the risk of heart attack more than other diabetes drugs, including Actos, the other drug in its class. A clinical trial is currently underway comparing the effects of Avandia and Actos. Many feel this trial is unethical, as it asks patients to take Avandia to see if it harms them, a purpose that contradicts the usual premise for a clinical trial.

While the study may be perceived as unethical, others argue that if Avandia remains on the market, the research is necessary to come to a more definitive conclusion.

Diabetes Medication Alternatives  

Since 2007, many doctors have switched their patients to other types of diabetes medications. In fact, sales of Avandia have fallen from $3 billion in 2006 to $1.2 billion. Pioglitazone, or Actos, is the most similar alternative, as it is in the same class of drugs as Avandia (thiazolidinediones).

Other classes of diabetes drugs,each of which work in different ways to lower blood sugar levels, include:

• Sulfonylureas
• Meglitinides
• Biguanides
• DPP-4 Inhibitors
• Alpha-glucosidase inhibitors

Learn more about oral medications for Type 2 diabetes.

If you have Type 2 diabetes and you take Avandia, do not stop taking your medication until you talk to your doctor about other options. Experts agree that making drastic changes without your doctor’s knowledge and supervision, such as not taking your current medication, can cause dangerous changes in your blood sugar levels and diabetes control.